Arch Therapeutics of Framingham has received U.S. Food and Drug Administration approval for a topical gel used to treat wounds.
Arch announced the milestone Monday but did not give a time frame for when it may reach the commercial market. The company has applied for similar regulatory health approval in Europe.
The product, called AC5 Topical Gel, is aimed at treating pressure sores, leg ulcers, diabetic ulcers and surgical wounds, the company said.
Arch, a public company, has yet to report any revenue. It reported $634,021 in research and development spending in the most recent quarter, but has otherwise warned it is on potential shaky financial footing.
The 12-year-old company said in a quarterly earnings report in August substantial doubt exists about the company’s ability to carry on operations while it has raised money largely through debt. Arch’s stock has been trading at less than $1 per share.
